FDAnews Device Daily Bulletin

A newly proposed EU regulation on in vitro diagnostic medical devices seeks to align IVD classification with the Global Harmonization Task Force’s risk-based model — a move that could place new requirements on the majority of current Class A IVDs by bumping them up to Class B. The new classification scheme would divide IVDs into four risk classes: A (lowest overall risk), B (moderate individual/low public health risk), C (high individual/moderate public health risk) and D (high overall risk).
International Medical Device Regulatory Monitor